A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.
• Previously untreated limited stage non bulky DLBCL; defined as limited stage by routine staging criteria in lymphoma involving FDG-PET and bone marrow biopsies (the Lugano criteria)\[21\]
• Patients with grade 3B follicular lymphoma and transformed indolent lymphoma are included
• Ages ≥ 18
• Measurable disease, assessable by radiographic examination with FDG-PET showing involvement
• Access to archived or fresh/frozen tumor biopsies
• No uncontrolled medical comorbidities
• Adequate cardiac function (EF \> or equal to 50%), no unstable angina
• Adequate renal function (GFR \> 60)
• Adequate liver function (liver function tests should be no greater than 2 x upper limit of normal) including normal bilirubin levels, no greater than 2 x upper limit of normal unless patient has a history of Gilbert's disease
• Adequate marrow reserves as indicated by complete blood count in the judgment of the treating investigator